MICRO ORGANISM GROWTH SYS-M1000

Device, Specimen Collection

HML INC/BIOTECHNOLOGY TRANSFER

The following data is part of a premarket notification filed by Hml Inc/biotechnology Transfer with the FDA for Micro Organism Growth Sys-m1000.

Pre-market Notification Details

Device IDK843000
510k NumberK843000
Device Name:MICRO ORGANISM GROWTH SYS-M1000
ClassificationDevice, Specimen Collection
Applicant HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill ,  NJ  08034 -
ContactJulius J Jablonsky
CorrespondentJulius J Jablonsky
HML INC/BIOTECHNOLOGY TRANSFER 950 KINGS HIGHWAY NORTH Cherry Hill ,  NJ  08034 -
Product CodeLIO  
CFR Regulation Number866.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-30
Decision Date1985-02-06

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